epic nitinol stent system in the treatment of atherosclerotic lesions in iliac arteries

Conditions: Iliac Artery Stenosis

Summary: the orion study is being conducted to determine whether the epic™ nitinol stent for primary stenting of iliac atherosclerotic lesions shows acceptable performance at 9 months.

orion is a prospective, single arm, non-randomized, multicenter study. a subject could receive a maximum of 2 study stents for up to 2 target lesions. a maximum of 1 non-target lesion in 1 non-target vessel could be treated with a commercially approved treatment during the index procedure.

Eligibility criteria:
inclusion criteria: * documented chronic, symptomatic iliac artery atherosclerotic disease (rutherford/becker category 1, 2, 3 or 4) * lifestyle-limiting claudication or rest pain * de novo or restenotic lesions in the common and/or external iliac artery * subjects with bilateral disease may have only one target lesion treated per side * two target lesions may be treated with a maximum of two stents (if two target lesions are treated, each lesion must be covered with a maximum of one stent) * length of diseased segment(s) \<=13 cm and treatment is planned with no more than 2 overlapped epic™ stents * baseline diameter stenosis \>= 50% (operator visual assessment) * reference vessel diameter \>= 5 mm and \<=11 mm * at least one sufficient ipsilateral infrapopliteal run-off vessel * origin of profunda femoris artery is patent exclusion criteria: * target vessel with in-stent restenosis * acute critical limb ischemia * tissue loss (rutherford/becker category 5 or 6) * any major amputations to the target limb * any minor amputation of the target limb in the last 12 months. if a minor amputation occurred greater than 12 months, stump needs to be completely healed. * life expectancy less than 24 months due to other medical co-morbid condition(s) that could limit the subject's ability to participate in the trial, limit the subject's compliance with the follow-up requirements, or impact the scientific integrity of the trial * known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated. * intolerance to antiplatelet, anticoagulant, or thrombolytic medications * platelet count \ 600,000 mm3 * serum creatinine \> 2.0 mg/dl * dialysis-dependent end stage renal disease * pregnancy * current participation in another drug or device trial that has not completed the primary endpoint or that may potentially confound the results of this trial * known allergy to nitinol * presence of arterial lesions (with the exception of renal, carotid or short, focal sfa lesions) requiring intervention within 30 days of the index procedure - superficial femoral artery occlusion in the limb supplied by target vessel * heavily calcified and/or excessively tortuous lesions in the target vessel as determined by angiography * target lesion is within or near an aneurysm * persistent, intraluminal thrombus of the proposed target lesion post-thrombolytic therapy * perforated vessel as evidenced by extravasation of contrast media * vascular graft, aneurysm or postsurgical stenosis of the target vessel * multiple lesions in the same target vessel unable to be treated with a maximum of two stents

Keywords: iliac artery stenosis claudication atherosclerotic iliac disease peripheral vascular disease